Vaccination process to start in India in a few weeks: Harsh
Pune-based Serum Institute of India (SII) may get emergency use nod for Covishield in India as soon as the UK’s drug regulator gives go ahead to the vaccine, which officials here expect to be before year end.
Union Health Minister Harsh Vardhan said at an event that in the coming weeks vaccination process will kick-start in India as soon as it is approved by the regulatory agency concerned. Sources said SII might take the lead in getting nod.
Dr Harsh Vardhan was speaking at the inter-ministerial meeting on vaccination of South Asia organised by the World Bank through video conference.
The sources said the Medicines and Healthcare Products Regulatory Agency (MHRA) is currently evaluating data, including which dosing regimen is best to use for the Covid vaccine developed by UK’s Oxford and AstraZeneca.
“The MHRA approval is expected before Christmas and India may give a go-ahead soon after that,” sources said.
“The regulatory approval in the UK is crucial to strengthen SII’s application seeking emergency use authorisation in India because the proposal here refers to trials being conducted in the UK and Brazil. Moreover, the vaccine is yet to be approved in any country. It is a sensitive matter and only once we are sure of the safety, efficacy and immunogenicity of the vaccine, we can grant an approval,” an official said.
The MHRA’s evaluation of data is likely to bring more clarity on dosage of the vaccine — which has shown efficacy of 62 per cent when two full doses were given to trial participants, but 90 per cent for a smaller sub-group given a half dose and then a full dose.
Vardhan said, “Effective planning and strategic management has enabled India to keep its cases per million at 7,078 against the global average of 8,883. The fatality rate is 1.45%, well below the global average of 2.29%.”